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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Leachables Study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P080012 / PAS003
Date Original Protocol Accepted 05/04/2012
Date Current Protocol Accepted 05/04/2012
Study Name Leachables Study
Device Name PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
Clinical Trial Number(s) NCT00817596 NCT00866164 
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a non-clinical study.
Study Population Not applicable. This is a bench/lab study.
Sample Size 8 Prometra pumps will be used in this study.
Key Study Endpoints Leachables Testing
The leachables study will use eight (8) Prometra pumps as required in the condition of approval. The solutions will be placebo solutions at the appropriate corresponding pHs. At each time-point pumps will be emptied of their contents through the catheters and 15 mLs of solution will be used for leachable testing. Pumps will then be refilled with 22 mL of placebo solutions. This schedule mimics actual use of the pumps (dispensing and refilling) and will allow sufficient sample for the leachables testing.

Controlled Extraction Study
The control extraction studies will involve the evaluation of extraction solutions of the materials of the Prometra pumps that come into contact with the drug product formulation. The accelerated extractions will be done using an Accelerated Solvent Extraction. The solvents to be used for extraction are purified water, water adjusted to pH 9.5, isopropanol, and hexane. The materials of the pump will be extracted in each of these solvents at reflux for 24 hours.
Follow-up Visits and Length of Follow-up Not applicable. This is a bench/lab study.


Leachables Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/07/2012 07/24/2012 On Time
1 year report 02/06/2013 02/06/2013 On Time
18 month report 08/07/2013 08/05/2013 On Time
2 year report 02/06/2014 02/06/2014 On Time
3 year report 02/06/2015 02/06/2015 On Time
4 year report 02/06/2016 02/05/2016 On Time
5 year report 02/05/2017 02/13/2017 Overdue/Received
6 year report 02/05/2018 02/13/2018 Overdue/Received
7 year report 02/05/2019 01/28/2019 On Time
8 year report 02/05/2020 02/10/2020 Overdue/Received
9 year report 02/04/2021 02/05/2021 On Time
10 year report 02/04/2022 02/08/2022 Overdue/Received
11 year report 02/04/2023 02/08/2023 Overdue/Received
12 year report 02/05/2024 02/05/2024 On Time
13 year report 02/05/2025 09/27/2024 On Time
14 year report 02/05/2026    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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